The European Food Safety Authority (EFSA) has launched a public consultation on a draft of its new guidance for preparing food additive applications. The Panel on Food Additive and Nutrient Sources Added to Food (ANS) developed this draft guidance to reflect the latest thinking in risk assessment whilst continuing to ensure the highest standards of consumer protection. This public consultation aims to generate feedback on the scientific data requirements and proposed three-tiered approach to risk assessment. All stakeholders and interested parties are invited to provide their comments through the online public consultation by 15 January 2012.
The draft guidance describes the data requirements and the risk assessment framework. This framework specifies the scientific criteria the ANS Panel intends to use when evaluating new food additive applications. The document is arranged in four main sections covering chemistry and specifications, existing authorisations and evaluations, proposed uses and exposure assessment, and toxicological studies.
In its draft guidance, the ANS Panel proposes a three-tiered approach for toxicological studies, which aims to balance data requirements against risk. Under this approach the results at Tier 1 can trigger additional data requirements, to be carried out at Tier 2. The findings of these additional data may then trigger the need for further specialised studies (Tier 3). The testing requirements, key issues and triggers of each tier are comprehensively described in the document. With this approach the ANS Panel aims to guide applicants in the design of their research methodology by identifying relevant data needs whilst strengthening the scientific basis for the risk assessment. Amongst the most significant developments are the use of a single animal species for toxicity testing and the introduction of an extended one-generation reproductive toxicity study.
In developing the guidance, the Panel has considered the latest scientific developments in risk assessment, including in particular, the important work done by EFSA’s Scientific Committee in several areas such as genotoxicity testing strategies and the safety assessment of botanicals.
This guidance will replace the previous guidance document of the European Commission’s Scientific Committee on Food (SCF) published in 2001.
The online public consultation is open until 15 January 2012. Feedback from the consultation will be compiled in a report and, where appropriate, incorporated into the revised draft guidance that the ANS Panel aims to adopt by July 2012.
This guidance refers to applications for new food additives or for new uses of authorised food additives.